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Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial
INTRODUCTION: Non-adherence to antiretroviral therapy (ART) is the main cause of viral non-suppression and its risk is increased by depression. In countries with high burden of HIV, there is a lack of trained professionals to deliver depression treatments. This paper describes the protocol for a 2-a...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9723911/ https://www.ncbi.nlm.nih.gov/pubmed/36576191 http://dx.doi.org/10.1136/bmjopen-2021-057844 |
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author | Abas, Melanie Mangezi, Walter Nyamayaro, Primrose Jopling, Rebecca Bere, Tarisai McKetchnie, Samantha M Goldsmith, Kimberley Fitch, Calvin Saruchera, Emily Muronzie, Thabani Gudyanga, Denford Barrett, Barbara M Chibanda, Dixon Hakim, James Safren, Steven A O’Cleirigh, Conall |
author_facet | Abas, Melanie Mangezi, Walter Nyamayaro, Primrose Jopling, Rebecca Bere, Tarisai McKetchnie, Samantha M Goldsmith, Kimberley Fitch, Calvin Saruchera, Emily Muronzie, Thabani Gudyanga, Denford Barrett, Barbara M Chibanda, Dixon Hakim, James Safren, Steven A O’Cleirigh, Conall |
author_sort | Abas, Melanie |
collection | PubMed |
description | INTRODUCTION: Non-adherence to antiretroviral therapy (ART) is the main cause of viral non-suppression and its risk is increased by depression. In countries with high burden of HIV, there is a lack of trained professionals to deliver depression treatments. This paper describes the protocol for a 2-arm parallel group superiority 1:1 randomised controlled trial, to test the effectiveness and cost effectiveness of the TENDAI stepped care task-shifted intervention for depression, ART non-adherence and HIV viral suppression delivered by lay interventionists. METHODS AND ANALYSIS: Two hundred and ninety people living with HIV aged ≥18 years with probable depression (Patient Health Questionnaire=>10) and viral non-suppression (≥ 1000 HIV copies/mL) are being recruited from HIV clinics in towns in Zimbabwe. The intervention group will receive a culturally adapted 6-session psychological treatment, Problem-Solving Therapy for Adherence and Depression (PST-AD), including problem-solving therapy, positive activity scheduling, skills to cope with stress and poor sleep and content to target barriers to non-adherence to ART. Participants whose score on the Patient Health Questionnaire-9 remains ≥10, and/or falls by less than 5 points, step up to a nurse evaluation for possible antidepressant medication. The control group receives usual care for viral non-suppression, consisting of three sessions of adherence counselling from existing clinic staff, and enhanced usual care for depression in line with the WHO Mental Health Gap intervention guide. The primary outcome is viral suppression (<1000 HIV copies/mL) at 12 months post-randomisation. ETHICS AND DISSEMINATION: The study and its tools were approved by MRCZ/A/2390 in Zimbabwe and RESCM-18/19–5580 in the UK. Study findings will be shared through the community advisory group, conferences and open access publications. TRIAL REGISTRATION NUMBER: NCT04018391. |
format | Online Article Text |
id | pubmed-9723911 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-97239112022-12-07 Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial Abas, Melanie Mangezi, Walter Nyamayaro, Primrose Jopling, Rebecca Bere, Tarisai McKetchnie, Samantha M Goldsmith, Kimberley Fitch, Calvin Saruchera, Emily Muronzie, Thabani Gudyanga, Denford Barrett, Barbara M Chibanda, Dixon Hakim, James Safren, Steven A O’Cleirigh, Conall BMJ Open HIV/AIDS INTRODUCTION: Non-adherence to antiretroviral therapy (ART) is the main cause of viral non-suppression and its risk is increased by depression. In countries with high burden of HIV, there is a lack of trained professionals to deliver depression treatments. This paper describes the protocol for a 2-arm parallel group superiority 1:1 randomised controlled trial, to test the effectiveness and cost effectiveness of the TENDAI stepped care task-shifted intervention for depression, ART non-adherence and HIV viral suppression delivered by lay interventionists. METHODS AND ANALYSIS: Two hundred and ninety people living with HIV aged ≥18 years with probable depression (Patient Health Questionnaire=>10) and viral non-suppression (≥ 1000 HIV copies/mL) are being recruited from HIV clinics in towns in Zimbabwe. The intervention group will receive a culturally adapted 6-session psychological treatment, Problem-Solving Therapy for Adherence and Depression (PST-AD), including problem-solving therapy, positive activity scheduling, skills to cope with stress and poor sleep and content to target barriers to non-adherence to ART. Participants whose score on the Patient Health Questionnaire-9 remains ≥10, and/or falls by less than 5 points, step up to a nurse evaluation for possible antidepressant medication. The control group receives usual care for viral non-suppression, consisting of three sessions of adherence counselling from existing clinic staff, and enhanced usual care for depression in line with the WHO Mental Health Gap intervention guide. The primary outcome is viral suppression (<1000 HIV copies/mL) at 12 months post-randomisation. ETHICS AND DISSEMINATION: The study and its tools were approved by MRCZ/A/2390 in Zimbabwe and RESCM-18/19–5580 in the UK. Study findings will be shared through the community advisory group, conferences and open access publications. TRIAL REGISTRATION NUMBER: NCT04018391. BMJ Publishing Group 2022-12-05 /pmc/articles/PMC9723911/ /pubmed/36576191 http://dx.doi.org/10.1136/bmjopen-2021-057844 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | HIV/AIDS Abas, Melanie Mangezi, Walter Nyamayaro, Primrose Jopling, Rebecca Bere, Tarisai McKetchnie, Samantha M Goldsmith, Kimberley Fitch, Calvin Saruchera, Emily Muronzie, Thabani Gudyanga, Denford Barrett, Barbara M Chibanda, Dixon Hakim, James Safren, Steven A O’Cleirigh, Conall Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial |
title | Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial |
title_full | Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial |
title_fullStr | Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial |
title_full_unstemmed | Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial |
title_short | Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial |
title_sort | task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with hiv: a study protocol for the tendai randomised controlled trial |
topic | HIV/AIDS |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9723911/ https://www.ncbi.nlm.nih.gov/pubmed/36576191 http://dx.doi.org/10.1136/bmjopen-2021-057844 |
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